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Description

Treatment is recommended to start with intramuscular injection of 1 ampoule (3 mL) daily until acute symptoms subside

The applicant stated that it believes that the nominated device meets the substantial clinical improvement threshold, given its novel mechanism addressing unmet need for recurrent nerve compression injuries, and requested that CMS consider the provided clinical data and recognize the Axoguard HA+ Nerve Protector TM as an innovative device offering improved clinical outcomes